Peripheral Neuropathy PainNCT07496398
Median and Ulnar Nerve Function in Tattoo Artists
An observational study of Peripheral Neuropathy Pain and Carpal Tunnel Syndrome (CTS), run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This case-control study aims to investigate the effects of occupational hand-arm vibration exposure on median and ulnar nerve functions in tattoo artists. Chronic exposure to vibration generated by tattoo machines may lead to neurosensory impairment, reduced tactile sensitivity, and decreased hand strength. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Neuropathy Pain, Carpal Tunnel Syndrome (CTS), Cubital Tunnel Syndrome
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 15 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Professional tattoo artists with at least one year of occupational exposure to vibration and age- and sex-matched healthy individuals.
Who may be able to join
- Age ≥ 18 years
- Professional tattoo artists with at least 1 year of occupational experience (case group)
- Healthy individuals without occupational vibration exposure (control group)
- Voluntary participation and provision of informed consent
- No upper extremity trauma or surgery within the last 6 months
Who cannot join
- Diagnosis of diabetes mellitus
- Diagnosis of peripheral neuropathy
- History of cervical radiculopathy or cervical disc herniation
- History of upper extremity surgery or injury
- Presence of rheumatologic or systemic inflammatory diseases
- Pregnancy
- Substance or alcohol abuse
- Engagement in a second occupation involving repetitive hand use or vibration exposure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational Hand-Arm Vibration Exposure and Its Effects on Median and Ulnar Nerve Function in Tattoo Artists: A Case-Control Study
This case-control study aims to investigate the effects of occupational hand-arm vibration exposure on median and ulnar nerve functions in tattoo artists. Chronic exposure to vibration generated by tattoo machines may lead to neurosensory impairment, reduced tactile sensitivity, and decreased hand strength. Objective assessments including nerve provocation tests, sensory threshold evaluation, two-point discrimination, vibration perception, grip and pinch strength measurements, and validated patient-reported outcome questionnaires will be used. Findings will be compared with age- and sex-matched healthy controls.
Read the detailed description
This observational cross-sectional case-control study evaluates neurosensory and motor function differences between professional tattoo artists exposed to long-term occupational vibration and healthy controls. Chronic exposure to hand-arm vibration (HAV) has been associated with peripheral neuropathy, entrapment neuropathies, and sensory receptor dysfunction.
Participants will undergo standardized assessment including:
Tinel, Phalen, reverse Phalen, and elbow flexion tests
Semmes-Weinstein monofilament testing
Two-point discrimination
Vibration perception testing (30 Hz and 256 Hz)
Grip and pinch strength measurements
Brief Michigan Hand Outcomes Questionnaire
Boston Carpal Tunnel Questionnaire
The study aims to determine whether occupational vibration exposure is associated with measurable alterations in median and ulnar nerve sensory and motor function.
- Medical subject headings
- Carpal Tunnel Syndrome, Cubital Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tattoo Artists (Vibration-Exposed) | Professional tattoo artists aged 18 years and older with at least one year of occupational exposure to hand-arm vibration generated by tattoo machines. Participants will undergo standardized sensory and motor assessments including nerve provocation tests, Semmes-Weinstein monofilament testing, two-point discrimination, vibration perception threshold, grip and pinch strength measurements, and validated hand function questionnaires. | |
| Healthy Controls | Age- and sex-matched healthy individuals without occupational vibration exposure and without history of upper extremity trauma, neuropathy, or systemic disease affecting nerve function. Participants will undergo the same standardized sensory and motor assessments as the case group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semmes-Weinstein Monofilament Threshold
Assessment of light touch sensory threshold using Semmes-Weinstein monofilaments applied to the index and little fingers.
Measured: Baseline (single assessment session)
Secondary outcomes (7)
Two-Point Discrimination
Minimum distance (mm) at which two points are perceived as separate on index and little fingers
Measured: Baseline (single assessment session)
Vibration Perception Duration
Duration (seconds) of vibration perception using tuning fork (30 Hz and 256 Hz)
Measured: Baseline (single assessment session)
Grip Strength
Maximal hand grip strength measured using a dynamometer (kg)
Measured: Baseline (single assessment session)
Pinch Strength
Lateral and tip pinch strength measured using a pinch gauge (kg)
Measured: Baseline (single assessment session)
Boston Carpal Tunnel Questionnaire Score
Symptom severity and functional status scores (1-5 scale)
Measured: Baseline (single assessment session)
Brief Michigan Hand Outcomes Questionnaire Score
Hand function score normalized to a 0-100 scale
Measured: Baseline (single assessment session)
Nerve Provocation Test Positivity
Presence of positive findings in Tinel, Phalen, reverse Phalen, and elbow flexion tests
Measured: Baseline (single assessment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Neuropathy PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sedanur Güngör, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496398
- Sponsor's protocol ID
- 2025-1981
- Status last verified
- Sep 2026
- First submitted
- 19 Mar 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Hand-Arm Vibration Exposure and Its Effects on Median and Ulnar Nerve Function in Tattoo Artists: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07496398
- Acronym / sponsor ID
- 2025-1981
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This case-control study aims to investigate the effects of occupational hand-arm vibration exposure on median and ulnar nerve functions in tattoo artists. Chronic exposure to vibration generated by tattoo machines may lead to neurosensory impairment, reduced tactile sensitivity, and decreased hand strength. Objective assessments including nerve provocation tests, sensory threshold evaluation, two-point discrimination, vibration perception, grip and pinch strength measurements, and validated patient-reported outcome questionnaires will be used. Findings will be compared with age- and sex-matched healthy controls.
Detailed description
This observational cross-sectional case-control study evaluates neurosensory and motor function differences between professional tattoo artists exposed to long-term occupational vibration and healthy controls. Chronic exposure to hand-arm vibration (HAV) has been associated with peripheral neuropathy, entrapment neuropathies, and sensory receptor dysfunction.
Participants will undergo standardized assessment including:
Tinel, Phalen, reverse Phalen, and elbow flexion tests
Semmes-Weinstein monofilament testing
Two-point discrimination
Vibration perception testing (30 Hz and 256 Hz)
Grip and pinch strength measurements
Brief Michigan Hand Outcomes Questionnaire
Boston Carpal Tunnel Questionnaire
The study aims to determine whether occupational vibration exposure is associated with measurable alterations in median and ulnar nerve sensory and motor function.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tattoo Artists (Vibration-Exposed) | – | –Professional tattoo artists aged 18 years and older with at least one year of occupational exposure to hand-arm vibration generated by tattoo machines. Participants will undergo standardized sensory and motor assessments including nerve provocation tests, Semmes-Weinstein monofilament testing, two-point discrimination, vibration perception threshold, grip and pinch strength measurements, and validated hand function questionnaires. |
| Healthy Controls | – | –Age- and sex-matched healthy individuals without occupational vibration exposure and without history of upper extremity trauma, neuropathy, or systemic disease affecting nerve function. Participants will undergo the same standardized sensory and motor assessments as the case group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Professional tattoo artists with at least one year of occupational exposure to vibration and age- and sex-matched healthy individuals.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Professional tattoo artists with at least 1 year of occupational experience (case group)
- Healthy individuals without occupational vibration exposure (control group)
- Voluntary participation and provision of informed consent
- No upper extremity trauma or surgery within the last 6 months
Key exclusion criteria (8 listed)
- Diagnosis of diabetes mellitus
- Diagnosis of peripheral neuropathy
- History of cervical radiculopathy or cervical disc herniation
- History of upper extremity surgery or injury
- Presence of rheumatologic or systemic inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Semmes-Weinstein Monofilament Threshold
Time frame: Baseline (single assessment session)
Assessment of light touch sensory threshold using Semmes-Weinstein monofilaments applied to the index and little fingers.
7 secondary outcomes
Two-Point Discrimination
Time frame: Baseline (single assessment session)
Vibration Perception Duration
Time frame: Baseline (single assessment session)
Grip Strength
Time frame: Baseline (single assessment session)
Pinch Strength
Time frame: Baseline (single assessment session)
Boston Carpal Tunnel Questionnaire Score
Time frame: Baseline (single assessment session)
Brief Michigan Hand Outcomes Questionnaire Score
Time frame: Baseline (single assessment session)
Nerve Provocation Test Positivity
Time frame: Baseline (single assessment session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Neuropathy Pain and Carpal Tunnel Syndrome (CTS), run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semmes-Weinstein Monofilament Threshold (time frame: Baseline (single assessment session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.